Prodisc C SK PDSLD6Recalls & reported problems
Centinel Spine, LLC · Prodisc C SK, Large Deep, 6mm · Class 3 · Implant
All models of Prodisc C SK (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843193113955), received between Dec 10, 2025 and Dec 10, 2025 — classified as 1 injury.
4 other recalls cover devices cleared under the same FDA submission (P070001); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Cerebrospinal Fluid Leakage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT WAS IMPLANTED WITH A SIMPLIFY DEVICE AT C4-5. IT WAS FOUND THAT THE DEVICE HAD MIGRATED POSTERIORLY INTO THE CANAL RESULTING IN A DURAL TEAR AND A CSF LEAK. THE SURGEON REMOVED THE SIMPLIFY DEVICE AND REPLACED IT WITH A PRODISC C SK DEVICE ON (B)(6) 2025. THE PDC SK DEVICE DID NOT RESOLVE THE CSF LEAK SO THE IMPLANT WAS REMOVED ON (B)(6) 2025 AND THE PATIENT WAS FUSED.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 23770906 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P070001. One submission often covers many models, so check the product and lot details in each record.
- Z-2050-2026 · Mar 20, 2026 · Open, ClassifiedProdisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
- Z-2051-2026 · Mar 20, 2026 · Open, ClassifiedProdisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.
- Z-1426-2026 · Dec 31, 2025 · Open, ClassifiedBrand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No
- Z-1406-2021 · Mar 5, 2021 · TerminatedProdisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for
Other Prosthesis, Intervertebral Disc devices
- Prodisc C SK PDSM5Centinel Spine, LLC · Prosthesis, Intervertebral Disc2 recalls4 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall12 reports
- Prodisc C 09.820.055SCentinel Spine, LLC · Prosthesis, Intervertebral Disc1 recall9 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall4 reports
- Prodisc C SK PDSXL5Centinel Spine, LLC · Prosthesis, Intervertebral Disc1 recall3 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall3 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall3 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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